MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	385400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the patient has a severe fatty acid oxidation disorder requiring a severely fat restricted diet supplemented with mct based formula.Failure to intake adequate calories can result in significantly elevated creatinine kinase level from rhabdomyolysis which can cause organ damage and could potentially be fatal.The patient is on continuous nocturnal g-tube feeds and occasionally, in times of illness, throughout the day as well.The feed pump was switched (b)(6) 2024, to the omni m761099.Since then, the pump has been clogging and beeping often.This has caused the patient to miss essential calories from the formula feeds at night, and she has been refusing to use it during the day when she requires it.On the noted date, she was showing symptoms of rhabdomyolysis, so a higher calorie formula recipe was required overnight.The pump clogged and malfunctioned many times throughout the night causing the patient to not receive the required calories and the patient continued rhabdomyolysis symptoms into the following day.The formula concentration is ~1 kcal/ml.The mct in the formula is likely causing the problem with the pump.
Additional Manufacturer Narrative
A non-conformance or service history review (shr) could not be conducted as no lot or serial number was provided with the complaint.The unit was not returned for evaluation; therefore, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Additional Manufacturer Narrative
D4 serial number was added.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21401966
• Report Number: 1423537-2025-00084
• Device Sequence Number: 12815810
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: (01)10192253065701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 385400
• Device Catalogue Number: 385400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025; 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown